Vildagliptin/metformin Aurovitas 50 mg/1,000 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Vildagliptin/Metformin Aurovitas 50 mg/850 mg Film-coated Tablets EFG

Vildagliptin/Metformin Aurovitas 50 mg/1.000 mg Film-coated Tablets EFG

vildagliptin/metformin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Vildagliptin/Metformin Aurovitas is and what it is used for
2. What you need to know before taking Vildagliptin/Metformin Aurovitas
3. How to take Vildagliptin/Metformin Aurovitas
4. Possible side effects
5. How to store Vildagliptin/Metformin Aurovitas
6. Contents of the pack and other information

1. What Vildagliptina/Metformina Aurovitas is and what it is used for

The active substances in this medicine, vildagliptin and metformin hydrochloride, belong to a group of medicines called "oral antidiabetics".

Vildagliptin/metformin is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus.

Vildagliptin/metformin is used when diabetes cannot be controlled by diet and exercise alone and/or with other antidiabetic medicines (insulin or sulfonylureas).

Type 2 diabetes occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It may also occur when the body produces too much glucagon.

Insulin and glucagon are produced in the pancreas. Insulin helps lower blood sugar levels, especially after meals. Glucagon promotes sugar production by the liver and causes blood sugar levels to rise.

How Vildagliptina/Metformina Aurovitas works

Both active substances, vildagliptin and metformin hydrochloride, help control blood sugar levels. The active substance vildagliptin stimulates the pancreas to produce more insulin and less glucagon. The active substance metformin helps the body to use insulin more effectively. This medicine has been shown to reduce blood sugar levels, which will help prevent complications of your diabetes.

2. What you need to know before starting to take Vildagliptin/Metformin Aurovitas

Do not take Vildagliptin/Metformin Aurovitas

• if you are allergic to vildagliptin, metformin hydrochloride, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these components, consult your doctor before taking this medicine.
• if you have uncontrolled diabetes, for example, with severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or fruity-smelling breath.
• if you have recently had a heart attack, or if you have heart failure, serious circulatory problems, or breathing difficulties that may be signs of heart problems.
• if you have severely reduced kidney function.
• if you have a serious infection or severe dehydration (massive loss of body water).
• if you are scheduled to undergo contrast radiography (a specific type of diagnostic X-ray test using an injectable contrast agent). For more information, see the section “Warnings and precautions”.
• if you have liver problems.
• if you drink alcohol excessively (daily or occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Risk of lactic acidosis

Vildagliptin/metformin may cause a very rare but very serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting, alcohol consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body has reduced oxygen supply (such as acute and serious heart diseases).

If any of the above apply to you, consult your doctor for further instructions.

Stop taking vildagliptin/metformin temporarily if you develop a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with extreme fatigue
• difficulty breathing
• decreased body temperature and heart rate

Lactic acidosis is a medical emergency and must be treated in a hospital.

Contact your doctor promptly for guidance if:

• You are known to have a genetic mitochondrial disorder (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You develop any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Vildagliptin/metformin is not a substitute for insulin. Therefore, you should not take this medicine for the treatment of type 1 diabetes.

Consult your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you are taking an antidiabetic medicine known as a sulfonylurea. Your doctor may wish to reduce your sulfonylurea dose when taken together with vildagliptin/metformin to avoid low blood glucose levels (hypoglycemia).

If you have previously taken vildagliptin but had to stop due to liver disease, you must not take this medicine.

Skin lesions are common complications of diabetes. Follow your doctor’s or nurse’s advice for skin and foot care. Pay special attention to the appearance of blisters or ulcers while taking vildagliptin/metformin. If this occurs, you must consult your doctor immediately.

If you require major surgery, you must stop taking vildagliptin/metformin during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart treatment with vildagliptin/metformin.

Liver function tests should be performed before starting treatment with vildagliptin/metformin, repeated every three months during the first year, and periodically thereafter. This is to detect as early as possible any signs indicating elevated liver enzymes.

During treatment with vildagliptin/metformin, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

Your doctor will periodically monitor your blood and urine glucose levels.

Children and adolescents

The use of vildagliptin/metformin is not recommended in children and adolescents under 18 years of age.

Other medicines and Vildagliptin/Metformin Aurovitas

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example, during an X-ray or scan, you must stop taking vildagliptin/metformin before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with vildagliptin/metformin.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of vildagliptin/metformin. It is especially important to mention the following:

• corticosteroids, generally used to treat inflammation.
• beta-2 agonists, generally used to treat respiratory disorders.
• other active substances used to treat diabetes.
• medicines that increase urine production (diuretics).
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• certain medicines affecting the thyroid gland.
• certain medicines affecting the nervous system.
• some medicines used to treat angina pectoris (e.g., ranolazine).
• some medicines used to treat HIV infection (e.g., dolutegravir).
• some medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib).
• some medicines used to treat stomach acid and peptic ulcers (e.g., cimetidine).

Taking Vildagliptin/Metformin Aurovitas with alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will inform you about the potential risks of taking vildagliptin/metformin during pregnancy.
• Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also “Do not take Vildagliptin/Metformin Aurovitas”).

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

If you feel dizzy while taking vildagliptin/metformin, do not drive or operate tools or machinery.

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This may be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is safe for you to drive or use machines.

Vildagliptin/Metformin Aurovitas contains maltodextrin

This medicine contains glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Vildagliptin/Metformin Aurovitas

The dose of vildagliptin/metformin required varies from person to person, depending on individual circumstances. Your doctor will tell you exactly what dose of vildagliptin/metformin you should take.

Always follow precisely the instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 50 mg/850 mg or 50 mg/1.000 mg film-coated tablet twice daily.

If you have reduced kidney function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking a diabetes medicine known as a sulfonamide derivative (sulfonylurea).

Your doctor may prescribe this medicine alone or together with certain other medicines that lower blood sugar levels.

When and how to take Vildagliptin/Metformin Aurovitas

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening, with meals or shortly after meals. Taking the tablet after meals will reduce the risk of gastrointestinal discomfort.

Follow your doctor's dietary advice. In particular, if you are following a diabetic weight control diet, continue this diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin Aurovitas than you should

If you have taken too many tablets of this medicine, or if someone else has taken your tablets, contact your doctor or pharmacist immediately. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the container and this leaflet with you.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Vildagliptin/Metformin Aurovitas

If you forget to take a tablet, take it with your next meal, unless it is almost time for your next scheduled dose. Do not take a double dose (two tablets at the same time) to make up for a missed dose.

If you stop taking Vildagliptin/Metformin Aurovitas

Continue taking this medicine for as long as your doctor prescribes it, to maintain control of your blood sugar. Do not stop treatment with vildagliptin/metformin unless your doctor tells you to. If you have any questions about how long you should take this medicine, consult your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

You must stop taking vildagliptin/metformin and contact your doctor immediately if you experience any of the following adverse effects:

• Lactic acidosis (very rare: may affect up to 1 in 10,000 people): this medicine may cause a very rare but serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms including swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (uncommon: may affect up to 1 in 100 people): symptoms including severe and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other adverse effects

Some patients have experienced the following adverse effects while taking vildagliptin/metformin hydrochloride:

• Common (may affect up to 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable trembling, constipation, nausea (feeling unwell), vomiting, diarrhoea, flatulence, heartburn, stomach and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite, swollen hands, ankles or feet (oedema), chills, inflammation of the pancreas, muscle pain.
• Very rare (may affect up to 1 in 10,000 people): signs of high levels of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe vomiting and nausea, abdominal pain, irregular heartbeat or deep, rapid breathing; skin redness, itching; decreased levels of vitamin B12 (pallor, tiredness, mental symptoms such as confusion or memory disturbances).

Since the marketing of this product, the following adverse effects have also been reported:

• Frequency not known (cannot be estimated from available data): localized peeling of the skin or blisters, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin/Metformin Aurovitas

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the blister and on the carton after "EXP". The expiry date refers to the last day of the month indicated.

• Do not store above 30°C.

• Store in the original packaging (blister) to protect from moisture.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina/Metformina Aurovitas

• The active substances are vildagliptin and metformin hydrochloride.

Each film-coated tablet of Vildagliptina/Metformina Aurovitas 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 660 mg of metformin).

Each film-coated tablet of Vildagliptina/Metformina Aurovitas 50 mg/1.000 mg contains 50 mg of vildagliptin and 1.000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).

• The other components are: copovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polydextrose, titanium dioxide (E171), talc, yellow iron oxide (E172), maltodextrin, medium-chain triglycerides.

Nature of the product and pack contents

Vildagliptina/Metformina Aurovitas 50 mg/850 mg film-coated tablets EFG are yellow, oval-shaped tablets, marked with "50" on one side and "850" on the other, with the following dimensions: length 21.6 ± 0.2 mm, width 8.6 ± 0.2 mm and thickness 7.4 ± 0.4 mm.

Vildagliptina/Metformina Aurovitas 50 mg/1.000 mg film-coated tablets EFG are dark yellow, oval-shaped tablets, marked with "50" on one side and "1000" on the other, with the following dimensions: length 22.0 ± 0.2 mm, width 9.0 ± 0.2 mm and thickness 8.1 ± 0.4 mm.

Vildagliptina/Metformina Aurovitas is presented in a cardboard box containing the corresponding number of blisters made of OPA/Al/PVC-Al or transparent PVC/PCTFE-Al.

Vildagliptina/Metformina Aurovitas is available in packs containing 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

or

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No.5

69300 Rodopi

Greece

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Vedfa

France: Vildagliptin/Metformine Arrow 50 mg/1000 mg, comprimé pelliculé

Spain: Vildagliptina/Metformina Aurovitas 50 mg/850 mg comprimidos recubiertos con película EFG and Vildagliptina/Metformina Aurovitas 50 mg/1.000 mg comprimidos recubiertos con película EFG

Italy: Vildagliptin e Metformina Aurobindo

Portugal: Metformina + Vildagliptina Generis

Greece: Vedfa

Cyprus: Vedfa

Date of the most recent review of this leaflet: May 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).